Patentability of biological processes: The Broccoli Case

The Enlarged Board of Appeal of the EPO (the highest instance of the EPO’s Boards of Appeal) is to consider a question of some importance to the patentability of methods of breeding and producing plants and animals. The question concerns the extent to which the exclusion to patentability of Article 53(b) EPC (see box overleaf) can be escaped.

The patent in question is for methods of producing new Brassica plants, in particular broccoli, with elevated levels of anticarcinogenic glucosinolates. The claimed method involves the selective breeding of “double haploid” lines of broccoli with wild species. The process would be deemed “essentially biological” (and therefore unpatentable) if it consisted entirely of natural phenomena such as crossing or selection (Rule 26(5) EPC 2000), but this is put in question by the inclusion of certain steps in the method claim that require human intervention (viz. selecting, through use of molecular markers, hybrids and plants having certain levels of glucosinates).

The patentability of the product claims (to the broccoli plants themselves) are not a subject of the referral. Inventions concerning plants have been regarded as patentable from the inception of the European Patent Convention and remain so under Rule 27(b) of the EPO 2000 (implementing Article 4(2) of the Biotechnology Directive).

Plant Bioscience Ltd is the proprietor of the patent, No. EP 1 069 819, which has so far been maintained in an amended form as a result of opposition and appeal proceedings brought by Syngenta and Limagrain. The Opponents argue that the patent should be revoked on the basis that the claims refer to an essentially biological process i.e. conventional breeding.

Various amicus briefs have been filed by interested parties. The case is pending as Referral G02/07.

EPC 2000 codifies the Biotechnology Directive

Rule 27 of the EPC 2000 provides that biotechnological inventions shall be patentable if they concern:

(a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;

(b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety; or

(c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.

Article 53(b) of the EPC 2000 excludes from patentability plant or animal varieties or essentially biological processes for the production of plants or animals (but this exclusion does not apply to microbiological processes or the products thereof).

By these provisions, the EU Directive 98/44/EC on the legal protection of biotechnological inventions is implemented in the European Patent Convention.

Comment

This Referral to the Enlarged Board of Appeal is of some importance, as the outcome will clarify the degree and nature of human technical intervention which is required to escape the process exclusion of Article 53(b) EPC.

It is seen as a test case for the patentability of conventional seeds and breeding methods and will set a precedent as to whether applications relating to crossing and selecting of plants and animals are likely to be allowable. On the one hand, many argue that the patent should be revoked on the basis that the patent does not refer to a genetically modified plant but rather covers conventional seeds and breeding methods. On the other hand, the opponents (who are involved in plant breeding themselves) are more interested in obtaining clarification from the EPO with regards to the exact interpretation of the exclusion.

Examination of many other applications in this field may be suspended until the Enlarged Board issues its decision.